Riociguat in Triple Therapy for Pulmonary Arterial Hypertension in Real-World Practice

NCT07374302 | Not Yet Recruiting

• 1 other identifier: SGP 27906
• Study Type: observational
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pulmonary arterial hypertension is a rare and serious disease that can lead to heart failure and early death despite modern treatments. Many patients are treated with a combination of medications targeting different disease pathways, but some continue to have an inadequate response. Riociguat is a medication that acts on the nitric oxide pathway and may be beneficial in patients who do not respond well to phosphodiesterase-5 inhibitors. In routine clinical practice, some patients receiving triple therapy switch from a phosphodiesterase-5 inhibitor to riociguat. The REAPPRAISED study evaluates outcomes in patients with pulmonary arterial hypertension who switched to riociguat while receiving triple therapy. This observational study uses data from routine clinical care and does not involve any experimental treatment. The results may help improve understanding of the effectiveness and safety of this treatment strategy in real-world practice.

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary Arterial Hypertension; Riociguat; Triple Therapy; Real-World Evidence; PDE5 Inhibitor Switch; Observational Study

Outcome Measures

Primary Outcomes (1)

• Composite Clinical Outcome at 6 Months

  Composite clinical outcome assessed at 6 months (24±8 weeks) after the switch to riociguat, defined as achievement of at least two of the following criteria: improvement in six-minute walk distance of at least 10% or 30 meters; World Health Organization functional class I or II; and reduction in BNP levels of at least 30%, in the absence of clinical worsening. Clinical worsening is defined as all-cause mortality, hospitalization due to pulmonary arterial hypertension, or unplanned therapeutic escalation.

  6 months (24±8 weeks) after switch

Secondary Outcomes (5)

• Persistence and Time to Discontinuation of Riociguat

  Up to 6 months

• Safety Outcomes

  Up to 6 months

• Health Care Utilization

  6 months before and 6 months after switch

• Functional Changes

  From baseline to 6 months

• Risk Stratification (COMPERA 2.0)

  From baseline to 6 months

Study Arms (1)

Riociguat Triple Therapy Cohort

Adult patients with pulmonary arterial hypertension receiving triple therapy who switched from a phosphodiesterase-5 inhibitor to riociguat as part of routine clinical care. The index date (T0) is defined as the date of riociguat initiation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes adult patients with pulmonary arterial hypertension receiving triple therapy who switched from a phosphodiesterase-5 inhibitor to riociguat in routine clinical practice at a specialized referral center. All patients were followed using retrospective data from medical records to assess clinical outcomes, safety, and treatment persistence. No study-related interventions were performed.

You may qualify if:

• Adults aged 18 years or older.
• Confirmed diagnosis of pulmonary arterial hypertension (Group 1).
• Treatment with triple therapy including an endothelin receptor antagonist, a prostacyclin pathway agent, and a phosphodiesterase-5 inhibitor for at least 12 weeks.
• Switch from a phosphodiesterase-5 inhibitor to riociguat as part of routine clinical care.
• Availability of minimum data to assess the primary outcome at 6 months.

You may not qualify if:

• Concomitant use of phosphodiesterase-5 inhibitors and riociguat.
• Inability to confirm vital status or hospitalization outcomes within 6 months.
• Participation in an interventional clinical trial that mandated the treatment switch.

Sponsors & Collaborators

• Caio Júlio César dos Santos Fernandes: lead

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Caio Fernandes, MD

  UNIVERSIDADE SAO PAULO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caio Fernandes, Principal Investigator, MD

CONTACT

+551126615034; cjcfernandes@yahoo.com.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 28, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share